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This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients have received or plan to receive CDK4/6 inhibitors for advanced disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDK4/6 inhibitor | Drug | CDK4/6 inhibitors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of starting CDK4/6 inhibitor to the date of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause in the absence of documented PD, whichever occurs first. | From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival is defined as the time from starting CDK4/6 inhibitor to death from any cause. | From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Hormone receptor-positive breast cancer patients who have received or plan to receive CDK4/6 inhibitors for advanced disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziping Wu, MD | Contact | 86(21)68385569 | wuziping@renji.com | |
| Qi Lu | Contact | 86(21)68383364 | rjllb3364@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Adverse events during CDK4/6 regimen will be assessed according to the NCI CTCAE v5.0.
| From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |